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The Scientist, Analytical Development & Quality Control is responsible for analytical development, feasibility, method qualification, routine, and stability testing of antibody drug conjugates and intermediates.
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Skills: Quality control, SOP, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System. General knowledge of industry standards and guidelines for quality control laboratory operation.
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CFS is seeking an experienced Quality Inspector to lead inspection and test activities for the SPARC project. Interface with Technicians on issues related to quality and help them in understanding and interpreting quality specifications and technical drawings.
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The Lead of Quality Control and Analytical Development is responsible for managing a team that provides quality oversight in support of clinical and commercial operations and analytical development of early and late-stage clinical products.
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PhaseForward Inform, Oracle Clinical and/or other clinical data management software desirable;General software skills: MS Access, MS Word, MS Excel, MS Project, Visio, familiarity with medical coding dictionaries, especially MedDRA and WHODRUG.Experience applying best practices in clinical data management programming in the clinical trial environment, including requirements definition and QC plansKnowledge of GCP and other regulations.
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Responsible for the proper operation and documentation all building systems, to include without limitation, fire alarm, fire sprinkler, security alarm, emergency lighting and signage, emergency egress, building access control, monitoring and recording, fuel distribution, elevators, generators, communications, disposal, sanitary, domestic water, plumbing, electric, heating, cooling, and ventilation.
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The Unit Manager provides leadership in the areas of customer service, hospitality, food preparation and service, menu development, procurement, inventory of food, supplies and equipment, quality control, food service sanitation, housekeeping, facility and equipment maintenance, food merchandising, special events management, accounts payable, payroll approval, employee performance management, and external relations.
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Monitor/control construction process through direction of on-site Superintendent to ensure project is built on schedule and within budget; investigate and identify all potential impacts to the project and implement corrective measures.
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The QA Supervisor will manage the quality of raw material, in-process material and finished product, ensuring the existing product manufacturing procedures, GMP, HACCP, weight control and other quality control procedures are followed and are updated when necessary.
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Must have strong knowledge of biologics and small molecules manufacturing, materials management, quality control, quality assurance and CMC regulatory requirements. Oversee suppliers and vendors involved in materials planning, inventory control, logistics, distribution to ensure that batch manufacturing is completed on a timely basis.
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The CLIA Quality Manager will collaborate with direct and/or delegated authority to ensure the CLIA Quality Management Systems (QMS) are effective and compliant with applicable requirements, provide leadership and guidance re: CLIA and associated regulations, and support the Lab Director and leadership in maintaining audit readiness.
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Performs daily calibration drift evaluation, and instrumentation check on CEMS. Participates in preparing quarterly QA/QC audits and reports and assists with and/or conducts yearly Nox RACT testing.
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Cleans the endoscopic equipment and the related accessories in the procedure rooms, prior to transporting to the cleaning room, according to Endoscopy Center established guidelines and infection control guidelines.
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Minimum of 6 years of experience in drug safety/pharmacovigilance quality assurance or compliance within the pharmaceutical or biotech industry. Certification in pharmacovigilance (e.g., RQAP-GLP, PVQA) or quality management (e.g., ASQ Certified Quality Auditor) is a plus.
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Examples of these groups include Infection Control; Emergency Planning / Business Resiliency; Move Coordination; and Strategic Sourcing. In addition to the oversight of contracted services and the leadership of the in-house maintenance teams, the Campus Operations Manager uses proven industry examples and past expertise to improve facilities-related processes and repair / replacement strategies which address the root cause of issues, rather than treating each preventive or corrective work order as a unique request.
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quality control qc manager jobs Title: project manager group in Needham Heights, MA
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